Content Uniformity

Content Uniformity Testing is useful for assessing the consistency of:

Powder blends before filling or compressing

Semi-solid and liquid bulk batches before filling

Filling during manufacturing (such as powders into capsules or liquids into vials or bottles)

Active content within individual units post-manufacturing (such as individual tablets after compression)

Content uniformity testing involves using a content/potency assay to determine the content of active material contained in multiple different samples collected throughout the batch.

Examples of sample sets that may be collected for content uniformity determinations are:

Tablets from the beginning, middle and end of a compression run. Aliquots of bulk material taken from the top, middle and bottom of a vessel before filling. Randomly selected bottles filled with a liquid taken out of a packaged case.Randomly selected capsules taken from a single bottle representing 10% of the number of capsules filled into the bottle.

Procedure:

Select 10 capsules or tablets at random. If using capsules empty contents of each capsule carefully in a suitable container. Using a suitable analytical method, assay the individual content of the active ingredient in each capsule or tablet.

The preparation complies if not more than one (all within limits) individual content is outside the limits of 85 to 115 % of the average content and none is outside the limits of 75 to 125 % of the average content. The preparation fails to comply with the test if more than 3 individual contents are outside the limits of 85 to 115 % of the average content or if one or more individual contents are outside the limits of 75 % to 125 % of the average content. According to INDIAN PHARMACOPOIEA Content of active ingredients. Determine the amount of active ingredient(s) by the method described in the Assay and calculate the amount of active ingredient(s) in each capsule. The result lies within the range for the content of active ingredient(s) stated in the monograph. This range is based on the requirement that 20 capsules, or such other number as may be indicated in the monograph, are used in the Assay. Where 20 capsules cannot be obtained, a smaller number, which must not be less than 5, may be used, but to allow for sampling errors the tolerances are widened in accordance with Table 1. The requirements of Table 1 apply when the stated limits are between 90 and 110 per cent. For limits other than 90 to 110 per cent, proportionately smaller or larger allowances should be made Weigh of Active Subtract Weigh of Active ingredients in each Capsules. The table is given in IP.